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Table 2 Sample sizes, mortality rates, absolute risk increases and number needed to harm (NNH) in adult critical care RCTs showing increased mortality in the intervention groups

From: Trials in adult critical care that show increased mortality of the new intervention: Inevitable or preventable mishaps?

References Sample size
Total (intervention/control)
Mortality rates
(n; %)
(intervention/control)
Difference in number of deaths P value Absolute risk increases (%) NNH
Hayes [10] 100 (50/50) 27/17
54/34 %
10 0.04 20 5
Fisher [15] 141 (108/33) 59/10
30/48/53/33 %a
(45/30)
49 0.02 15 6.6
Sloan [14] 98 (52/46) 24/8
46/17 %
16 0.03 29 3.5
Takala [13]a 280 (119/123) 46/24
39/20 %
22 <0.001 19 5.3
Edwards [17] 10,008 (5007/5001) 1248/1075a
25.7/22.3 %
173 0.0001 5 20
Perner [12] 798 (398/400) 203/172
51/43 %
31 0.03 8 12.5
Ferguson [16] 548 (275/273) 129/96
47/35 %
33 0.005 12 8.3
Finfer [8] 6030 (3016/3014) 829/750
27.5/24.9 %
79 0.02 2.6 38.5
Lopez [11] 797 (439/358) 259/175
59/49 %
84 <0.001 10 10
Gao Smith [9] 326 (162/164) 55/38
34/23 %
17 0.02 11 9
Totals or means 19,126 (9626/9462) 2879/2365
29.9/25 %
514   5 20
  1. Four-week mortality rates of albumin versus control groups
  2. In Fisher [15] RCT TNF-α receptor, the primary analysis was a trend test of placebo and increasing doses of TNF-α receptor. Mortality rates are shown for the dose groups and then for the combined intervention versus control groups (45/30)
  3. aSix-month mortality rates of methylprednisolone versus placebo